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Reported covered position: Legislative Assistant - Sen. Frank Lautenberg
How to read the money
Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2026 · third_quarter · Q3
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Source: Senate LDA
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
To amend the Impoundment Control Act of 1974 to require prior approval from Congress before the Comptroller General may pursue a civil action under such Act, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
To amend the Impoundment Control Act of 1974 to require prior approval from Congress before the Comptroller General may pursue a civil action under such Act, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Protecting Patient Access to Cancer and Complex Therapies Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
340B PATIENTS Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
340B ACCESS Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Pharmacists Fight Back in Medicare and Medicaid Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
Most Favored Patient Act of 2026
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
CLEAR LABELS Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
SECURE 340B Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Drug Competition Enhancement Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Stop STALLING Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Preserve Access to Affordable Generics and Biosimilars Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Biosimilar Red Tape Elimination Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
340B PATIENTS Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Medication Affordability and Patent Integrity Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to IRA H.R.1 492 , S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
PLASMA Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarifying or reforming the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Customs Border Protection changes impacting southern border plasma collections Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 1476, S. 694, PLASMA Act H.R. 2528, Association Health Plans Act H.R. 2214, DRUG Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarifying or reforming the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Customs Border Protection changes impacting southern border plasma collections Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 1476, S. 694, PLASMA Act H.R. 2528, Association Health Plans Act H.R. 2214, DRUG Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 2214, DRUG Act HP. 4299 - Protecting Patient Access to Cancer and Complex Therapies Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues H.R. 2214, DRUG Act
Association Health Plans Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarifying or reforming the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Customs Border Protection changes impacting southern border plasma collections Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 1476, S. 694, PLASMA Act H.R. 2528, Association Health Plans Act H.R. 2214, DRUG Act
To amend the Impoundment Control Act of 1974 to require prior approval from Congress before the Comptroller General may pursue a civil action under such Act, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
To amend the Impoundment Control Act of 1974 to require prior approval from Congress before the Comptroller General may pursue a civil action under such Act, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to IRA H.R.1 492 , S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
PLASMA Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarifying or reforming the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Customs Border Protection changes impacting southern border plasma collections Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 1476, S. 694, PLASMA Act H.R. 2528, Association Health Plans Act H.R. 2214, DRUG Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to IRA H.R.1 492 , S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 HR10445 Continuing Resolution through 3/17/2025 HR 9747, Continuing Appropriations and Extensions Act, 2025
Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 HR10445 Continuing Resolution through 3/17/2025 HR 9747, Continuing Appropriations and Extensions Act, 2025
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
American Innovation and R&D Competitiveness Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits Administration's Global Tax Proposal S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization
Pharmacy Benefits Manager Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefit Manager Sunshine and Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefit Manager Sunshine and Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Protecting Patients Against PBM Abuses Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Protecting Patients Against PBM Abuses Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Lower Costs, More Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Lower Costs, More Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Lower Costs, More Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Lower Costs, More Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
BIOSECURE Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
HELP Copays Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
HELP Copays Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
HELP Copays Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
HELP Copays Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Clinical Trial Modernization Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 HR 8412 Clinical Trials Modernization Act
340B ACCESS Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
340B ACCESS Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
340B ACCESS Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
340B ACCESS Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Continuing Appropriations and Extensions Act, 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 HR10445 Continuing Resolution through 3/17/2025 HR 9747, Continuing Appropriations and Extensions Act, 2025
Continuing Appropriations and Extensions Act, 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 HR10445 Continuing Resolution through 3/17/2025 HR 9747, Continuing Appropriations and Extensions Act, 2025
Prescription Pricing for the People Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Drug Price Transparency Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Drug Price Transparency Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
SMART Prices Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
SMART Prices Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefit Manager Transparency Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefit Manager Transparency Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefit Manager Reform Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefit Manager Reform Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
HELP Copays Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
Administration's Global Tax Proposal Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2026 · second_quarter · Q2
Clarify or reform the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues SECURE 340B Act (bill# not listed yet) Senate Finance Committee Drug Pricing RFI
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Filing targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2026 · first_quarter · Q1
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2025 · fourth_quarter · Q4
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues H.R. 2214, DRUG Act
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2025 · third_quarter · Q3
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Clarify or reform the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 2214, DRUG Act HP. 4299 - Protecting Patient Access to Cancer and Complex Therapies Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2025 · second_quarter · 2A
FY 2025 Budget Resolution - Pharmaceutical Related Provisions
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2025 · second_quarter · Q2
FY 2025 Budget Resolution - Pharmaceutical Related Provisions
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2025 · first_quarter · Q1
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits Administration's Global Tax Proposal General issues around 2025 Reconciliation/Inbound Concerns
General intellectual property policy issues Issues related to proposed tariffs - all pharmaceutical related provisions
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to IRA H.R.1 492 , S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2024 · fourth_quarter · 4A
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Medicare payment proposals Medicare telehealth proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2024 · fourth_quarter · Q4
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Medicare payment proposals Medicare telehealth proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2024 · third_quarter · Q3
General intellectual property policy issues
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2024 · second_quarter · Q2
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 HR 8412 Clinical Trials Modernization Act
Administration's Global Tax Proposal General issues around 2025 Reconciliation/Inbound Concerns
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Administration's Global Tax Proposal General issues around 2025 Reconciliation/Inbound Concerns
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Clarifying or reforming the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Customs Border Protection changes impacting southern border plasma collections Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 1476, S. 694, PLASMA Act H.R. 2528, Association Health Plans Act H.R. 2214, DRUG Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 HR10445 Continuing Resolution through 3/17/2025 HR 9747, Continuing Appropriations and Extensions Act, 2025
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 HR10445 Continuing Resolution through 3/17/2025 HR 9747, Continuing Appropriations and Extensions Act, 2025
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits Administration's Global Tax Proposal S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027
Filing targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE